Director, Clinical Pharmacology
Locations: King of Prussia, PA or Glattbrugg, Switzerland
Work Arrangement: Hybrid ? 3 days onsite
Reports To: Senior Director, Clinical Pharmacology Lead
About CSL
CSL?s R&D organization is accelerating innovation to deliver greater impact for patients. Through a project-led structure and a strong focus on collaboration, we are building a future-ready organization that thrives in dynamic biotech ecosystems. Join CSL and become part of an agile team committed to developing innovative therapies that make a meaningful difference for patients around the world.
The Opportunity
CSL is seeking a Director, Clinical Pharmacology to provide clinical pharmacology and pharmacometrics expertise across a range of programs within its R&D portfolio. This individual will lead clinical pharmacology strategy, guide pharmacokinetic/pharmacodynamic (PK-PD) assessments, and drive the application of modeling and simulation to support drug development decisions throughout the clinical development lifecycle.
The successful candidate will operate with a high degree of independence, bringing strong scientific expertise, innovative thinking, and a solution-oriented approach to cross-functional collaboration. Working closely with clinical development, research, translational science, biostatistics, and other R&D partners, the Director will ensure the integration of clinical pharmacology strategies into global development plans.
This role will also serve as a key clinical pharmacology representative in regulatory interactions, contributing to submission documents, regulatory responses, and discussions with health authorities to support successful development and registration of therapies.
Main Responsibilities and Accountabilities
- Clinical Pharmacology Strategy: Lead clinical pharmacology and PK-PD strategies for assigned programs across the R&D portfolio, partnering with pharmacometricians, clinical program directors, clinical scientists, biostatisticians, and other cross-functional colleagues.
- Clinical Study Design and Oversight: Lead the design of clinical pharmacology studies and relevant protocol sections across all stages of drug development. Provide scientific oversight of study implementation in collaboration with Clinical Development, Clinical Safety, and Clinical Research Operations.
- Pharmacokinetic and PK-PD Analyses: Plan and implement appropriate pharmacokinetic and pharmacodynamic analyses, including non-compartmental analysis and other relevant analytical approaches, to inform clinical development decisions.
- Data Interpretation and Reporting: Lead the review and interpretation of clinical pharmacology study results, ensuring high-quality presentation and documentation in clinical study reports, scientific publications, and related study materials.
- Cross-Functional Collaboration: Represent clinical pharmacology and pharmacometrics on clinical development teams, ensuring alignment across functions and integration of clinical pharmacology strategies into global development plans.
- Modeling and Simulation: Apply innovative pharmacometric methodologies, including modeling and simulation, to integrate pharmacokinetics, pharmacodynamics, patient characteristics, and disease states. Use these insights to inform dose selection, study design, and development strategies throughout the clinical development lifecycle.
- Regulatory Strategy and Submissions: Provide clinical pharmacology expertise for protocols, Investigator?s Brochures, regulatory submissions, product labeling, and other regulatory documentation. Lead the development of clinical pharmacology strategies and written responses to health authority questions, and contribute to regulatory meetings and filing activities as needed.
- Research and Translational Science Support: Partner with Research and Translational Science teams to develop preclinical PK-PD knowledge supporting early clinical development strategies and appropriately incorporate pharmacology and toxicology data into early clinical study design.
- External Scientific Engagement: Establish and maintain relationships with external scientific experts and key opinion leaders in clinical pharmacology to support scientific exchange and advance development approaches.
Qualifications and Experience
- PhD or PharmD in Clinical Pharmacology, Pharmacology, Pharmaceutical Sciences, or a related scientific discipline.
- A clinical pharmacology research fellowship is preferred.
- Minimum of 8 years of relevant industry experience for Director-level candidates with a PhD or PharmD, specifically contributing to clinical pharmacology aspects of clinical drug development.
- Extensive experience in clinical pharmacology, particularly pharmacokinetics, pharmacodynamics, and PK-PD strategy.
- Experience supporting clinical drug development programs across relevant stages of development.
Technical Expertise
- Advanced understanding of clinical pharmacology principles, including clinical trial design and conduct.
- Strong knowledge of pharmacokinetic and PK-PD data analysis, interpretation, and application in drug development.
- Experience with population pharmacokinetic methodologies and interpretation of related analyses.
- Understanding of the use of biomarkers to inform clinical development decisions.
- Demonstrated technical expertise in pharmacometrics methodologies and their practical application, including modeling and simulation.
- Experience contributing to regulatory submissions, clinical pharmacology documentation, and responses to health authority questions.
- Ability to integrate clinical and nonclinical data to inform dose selection, study design, and clinical development strategies.
Our Commitment
At CSL, we are committed to developing innovative therapies that improve patients? lives. Join a collaborative, science-driven R&D organization where your expertise in clinical pharmacology and pharmacometrics will help shape development strategies and advance meaningful medical innovation.
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